In Life Sciences manufacturing quality and compliance, the global digitalisation drive continues a-pace as the pressure builds to innovate, collaborate and contain costs. REPHINE’s Dr. Eduard Cayón rounds up the latest trends and challenges facing drug makers and their supply chain partners.
2023 has been a demanding year for Life Sciences manufacturing, with continued pressure to innovate, bring costs down and overcome very real global supply chain disruption through improved visibility and contingency planning. The most significant and serious pharma R&D projects are concentrated in the biotech space now. Although small-molecule developments are still a focus of investment, this once dominant field is becoming steadily less strategically important. As a natural consequence, increased technology use has become a priority – both to support designated innovation and to help deliver this efficiently and safely. Efforts to digitise and automate manufacturing operations and processes in smarter ways have seen a sharp acceleration in initiatives over the last year, coupled with a renewed commitment to tech-based process monitoring and improvement – among operations of all sizes.
Agility, flexibility, and robust transparency in front of regulators are among the reasons drug producers are upping their game technologically. All market players realise now that targeted technology use offers not only a way to expedite product delivery and contain risk and cost; but also connect in more fluid and traceable ways with other entities – from regulators, to supply chain partners, to clinical trial participants and sponsors. Tools are much more accessible and affordable now, certainly. As a result, digitalisation of manufacturing operations and associated quality control has become a competitive imperative. That’s as manufacturers across the world, from India and China to the Middle East and South America become more technologically advanced, and at an accelerating pace. Even active ingredient (API) producers are investing in the automation of operations monitoring processes that were previously managed manually.
Digital tool use isn’t just for manufacturing operations oversight or laboratory quality control processes either, but also overall Quality management. Changes to everyday working practices during pandemic lockdowns, and extended remote working, have added impetus for Quality-related process change. Hybrid working and remote collaboration are now seen as an enduring model – supported by the cloud as a secure hub for sharing and exchanging information, across global operations and along the supply chain. That’s as the benefits have been felt in process efficiency and overall transparency.
Feeding into these already established digital capability priorities, we have seen the growing need for:
The pandemic underscored the significance of being adaptable and swiftly shifting production, research and development, not least because of the need to respond promptly to new viral or bacterial threats in the future. All of this demands that operations are comprehensively and reliably monitorable and that relationships along the supply chain are strong but fluid, underpinned by a continuous, consistent information flow.